ARMO BioSciences has begun dosing patients in a Phase III clinical trial of AM0010 (PEGylated Interleukin-10) and FOLFOX combination for the treatment of advanced pancreatic cancer.
AM0010 is a long-acting form of recombinant human interleukin-10 (IL-10) currently being developed to stimulate the activation, proliferation and survival of intra-tumoural, tumour-reactive, cytotoxic CD8+ T-cells in patients.
The international, randomised Phase III trial is designed to assess the AM0010 + FOLFOX combination as a second-line therapy compared to FOLFOX alone in a total of 566 patients.
ARMO president and chief executive officer Peter Van Vlasselaer said: "Dosing the first patient in a Phase III trial is an important milestone in our effort to develop our novel immunotherapy for this very aggressive form of cancer.
"We chose pancreatic cancer for our first pivotal Phase III trial based on encouraging Phase I/Ib data with AM0010 as a single agent and in combination with FOLFOX.
"In our clinical experience with AM0010, we observed durable clinical responses in several cancer types. Additionally, we observed systemic and intra-tumoural stimulation of CD8+ T-cell survival, expansion and cytotoxic activity."
The trial's primary endpoint is overall survival (OS), while secondary endpoints include progression-free survival (PFS), overall response rate (ORR) and safety.
The trial will also determine exloratory endpoints of biomarkers that may be associated with tumour response, immune activation and clinical efficacy outcomes.
AM0010 has secured orphan drug designation from the US Food and Drug Administration (FDA) and the European Commission (EC), as well as fast-track designation from FDA in combination with FOLFOX.